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Correction for Parulekar and Eisenhauer, J. Natl. Cancer Inst. 96 (13) 990-997.
JNCI Journal of the National Cancer Institute 2004 96(21):1640; doi:10.1093/jnci/djh317
© 2004 by Oxford University Press
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© 2004 Oxford University Press

CORRESPONDENCE

Erratum

Erratum: "Phase I Trial Design for Solid Tumor Studies of Targeted, Non-Cytotoxic Agents: Theory and Practice" by Parulekar and Eisenhauer [J Natl Cancer Inst 2004;96:990–7 (Issue 13)]. Three of the studies examined and counted as separate trials were in fact duplicates of three trials already included. Thus, a total of 57 (rather than 60) trials were reviewed. Below are minor corrections to the data on primary outcomes (reasons for halting dose escalation and major determinant of recommended dose), that take this finding into account.

Table 3: Thirty-six (63%) of 57 trials, rather than 36 (60%) of 60, had dose escalation halted for reasons of toxicity. Seven (12%) of 57 trials, rather than 8 (13%) of 60, halted escalation for pharmacokinetic data. Finally, 3 (5%) of 57 trials, rather than 5 (8%) of 60, were halted on the basis of the maximum planned dose.

Table 4: Five (9%) of 57 trials, rather than 6 (10%) of 60, had no dose recommendation stated. Nine (16%) of 57 trials, rather than 11 (18%) of 60, had pharmacokinetic data as the primary basis for dose recommendation.

The change in the number of trials considered had no impact on the major conclusion that the overwhelming reason for both halting dose escalation and dose recommendation was treatment-related toxicity. The authors regret the error.


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